CompletedNot Applicable

Nitrate Mouth Rinse and the Oral Microbiome

Canada21 participantsStarted 2024-08-14

Plain-language summary

The study is aimed to determine if changes to the oral microbiome occur after the use of a nitrate rich mouth rinse. Participants with be asked to use either a controlled (water) mouthrinse once daily for 2 weeks while maintaining normal oral hygiene practices, or use the nitrate rich mouthrinse once daily for 2 weeks. Primary Outcome measures: -changes in the composition of the oral microbiome Secondary Outcome measures * Blood Pressure * Salivary Nitric Oxide Levels

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * You are between the ages of 18 and 40. Have no uncontrolled systemic diseases. Participants with mild chronic conditions such as: * Asthma * Type 1 Diabetes Mellitus Exclusion Criteria: * You are under the age of 18. * You have uncontrolled systemic diseases, or acute infections. * You are taking prescription, antibiotics, probiotics, or antimicrobial mouthrinses. * You have a documented true allergy (i.e Hives, Swelling of lips/throat) Soy, Nuts, Seeds, Dairy, Egg products, Fish/Shellfish or Wheat. * The presence of acute or chronic oral conditions including: * Herpes Simplex Virus (recent cold sores) * Stomatitis * Oral Lichen Planus * Angular Cheilitis * Candidiasis * Necrotizing Gingival Diseases * Other inflammatory or infectious pathologies * Active dental caries "cavities" * Any other periodontal diagnosis other than 'Healthy Periodontium' or localized gingivitis

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Microbial composition

Timeframe: 2 weeks

Trial details

NCT IDNCT06588049

SponsorDalhousie University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-16

View on ClinicalTrials.gov More Nitric Oxide trials